A phase 3 study of the drug molnupiravir, developed by the pharmaceutical company MSD (called Merck in the United States and Canada) found an efficacy in reducing the risk of hospitalization for Covid of more than 65%, when compared to standard treatment alone.
The research evaluated 1,218 adult patients at high risk for Covid-19. It was observed that using two 800 mg pills of the drug for five days in patients up to five days after the onset of symptoms reduced the risk of hospitalization and death from Covid compared to patients who did not receive the treatment.
The preliminary results of this clinical trial, conducted in India, were released by the pharmaceutical company MSD last Saturday (19). Still according to the company, there were no deaths from treatment in the study.
The results of the global MOVe-OUT study, which evaluated the drug in about 1,400 volunteers in 23 countries, including the United States, United Kingdom and Brazil, released in October 2021, showed an initial efficacy of 50% reduction in risk. of hospitalization. Subsequently, this reduction dropped to 30%.
Last November, the UK became the first country to approve MSD’s Covid pill.
Then, the FDA, the agency that regulates drugs and food in the United States, authorized the use of molnupiravir in specific situations, such as high risk for hospitalization and after a diagnosis of Covid-19 has been determined. There is no indication so far for prophylactic use (pre-exposure prevention) of the drug.
In Brazil, MSD submitted a request for authorization for emergency use of the antiviral in November, but it is still awaiting a determination from Anvisa (National Health Surveillance Agency), which requested new information.
Anvisa’s response period after application submission is 30 days, but the counting of this period is paused when the agency asks the manufacturer for additional information. In a note, the agency informed that the request is within the regulatory deadline and that, therefore, it is not possible to anticipate details or deadlines.
The Indian trial refers to a non-exclusive licensing agreement between MSD and its partner, Ridgeback Biotherapeutics, to produce and test the drug in 100 low-income countries.
When contacted, MSD said that it did not send the data from the Indian study to Anvisa, as they correspond to the generic drug molnupiravir, but said that, if approved by the agency, the pharmaceutical company is in advanced talks with Fiocruz to produce and widely offer the drug. for the entire Brazilian population.
Last week, an article published in the scientific journal Nejm (The New England Journal of Medicine) confirmed the data from the molnupiravir trial in non-hospitalized adults, with a reduction in the risk of hospitalization by 30% and death from Covid by 89%.
A total of 1,433 people participated in the randomized, controlled, double-blind study (gold standard for clinical trials), of which 716 received the drug and 717 formed the control group (received placebo).
The antiviral’s mechanism of action, discovered by researchers at Emory University in Atlanta, Georgia (USA), and developed by Miami-based biotechnology company Ridgeback Biotherapeutics in partnership with MSD, consists of a protein that forms RNA (genetic material) of the modified virus, binds to the viral genome and prevents its replication.
According to the Nejm study, participants who used the drug recorded for a shorter time the presence of genetic material from the virus in the nose, mouth and throat, indicating the effectiveness of the drug also in eliminating the coronavirus from the body. Experts, however, say that antiviral drugs should not replace vaccination against Covid-19.
In the same issue of the journal, an editorial was published defending the use of this and other antiviral drugs, such as Paxlovid, from Pfizer, and remdesivir, from the pharmaceutical company Gilead Sciences, especially in the initial treatment of Covid-19.
In Brazil, until now, Anvisa has only authorized remdesivir for use in hospitalized patients with pneumonia who need oxygen support, but the drug has not yet been incorporated into the SUS.
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